MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number BG UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, "poster presentation at acc 2020 world congress of cardiology: background: patients presenting with elevated prosthetic valve gradients at intermediate follow up can pose diagnostic challenges.Herein we report a rare surgical complication manifest as elevated aortic valve gradients, warranting repeat surgical intervention case: a (b)(6) year old woman with a history of atrial flutter, hypertension and bicuspid aortic valve underwent aortic valve replacement with a 21mm [mechanical valve] in 2015.3 years later, the patient presented with worsening shortness of breath over a 4 month period.He did not report symptoms concerning for infection.Echocardiogram revealed worsening gradients across the av (pk/mn gradients:85/51mmhg,ava 1.1cm2,di: 0.22) with preserved lv and rv function, compared to baseline.Coronary angiogram revealed no obstructive disease.Basic blood work was unremarkable.The patient was subsequently referred to our facility for consideration of [redacted] decision-making: ct chest revealed a 2.2cm x 1.4cm hypoattentating fluid density adjacent to the non-coronary sinus extending into the interatrial septum.Tee performed to characterize this further showed an echodense appearance above the aortic valve annular plane extending posteriorly along the proximal aorta with pulsatility suggestive of a thrombosed pseudo-aneurysm.With these findings, the patient was offered re-do savr and pseudoaneurysm repair.Intra-operative findings demonstrated accumulation of bioglue extending to the innominate artery at the region of suspected pseudoaneurysm.This was compressing the aortic valve thereby explaining the elevated gradients in the context of normal structural morphology of valve leaflets.Bioglue was likely placed to achieve hemostasis during prior surgery as evidenced by the presence of [redacted] eroding the aorta.The patient underwent redo-avr with a 23mm [mechanical valve]+maze+bioglue debridement.".

Manufacturer Narrative

No additional information was made available.The manufacturing records were not reviewed since the publication did not list a bioglue lot number or any dates of procedure.The following information was not provided and is unknown: the amount of bioglue applied, and the condition of the native tissue.Dr.(b)(6) performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Resented at the 15th world congress of heart disease in vancouver, canada in (b)(6) 2010 they identified 97 consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow-up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, ¿the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease.¿ (ma 2017) there is insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysm formed in the procedure.However, the author¿s comment, ¿the presence of [redacted] eroding in the aorta¿ suggests that sutures from the initial surgery likely played a significant role in the adverse event.Additionally, the condition of the native aortic tissue at the time of initial surgery is unknown in this case.Pre-existing conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.All risks identified have been mitigated as far as possible and residual risk is acceptable.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the initial report, "poster presentation at acc 2020 world congress of cardiology: background: patients presenting with elevated prosthetic valve gradients at intermediate follow up can pose diagnostic challenges.Herein we report a rare surgical complication manifest as elevated aortic valve gradients, warranting repeat surgical intervention case: a 63 year old woman with a history of atrial flutter, hypertension and bicuspid aortic valve underwent aortic valve replacement with a 21mm [mechanical valve] in 2015.3 years later, the patient presented with worsening shortness of breath over a 4 month period.He did not report symptoms concerning for infection.Echocardiogram revealed worsening gradients across the av (pk/mn gradients:85/51mmhg,ava 1.1cm2,di: 0.22) with preserved lv and rv function, compared to baseline.Coronary angiogram revealed no obstructive disease.Basic blood work was unremarkable.The patient was subsequently referred to our facility for consideration of [redacted] decision-making: ct chest revealed a 2.2cm x 1.4cm hypoattentuating fluid density adjacent to the non-coronary sinus extending into the interatrial septum.Tee performed to characterize this further showed an echodense appearance above the aortic valve annular plane extending posteriorly along the proximal aorta with pulsatility suggestive of a thrombosed pseudo-aneurysm.With these findings, the patient was offered re-do savr and pseudoaneurysm repair.Intra-operative findings demonstrated accumulation of bioglue extending to the innominate artery at the region of suspected pseudoaneurysm.This was compressing the aortic valve thereby explaining the elevated gradients in the context of normal structural morphology of valve leaflets.Bioglue was likely placed to achieve hemostasis during prior surgery as evidenced by the presence of [redacted] eroding the aorta.The patient underwent redo-avr with a 23mm [mechanical valve]+maze+bioglue debridement.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11031427
• MDR Text Key: 222317564
• Report Number: 1063481-2020-00035
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/18/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR